CSL and Arcturus Launch New mRNA COVID-19 Vaccine in Japan

CSL and Arcturus' mRNA Vaccine Approved in Japan

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) along with innovative vaccine company Arcturus Therapeutics has exciting news to share. Japan's health authorities have given the green light for their latest self-amplifying mRNA (sa-mRNA) COVID-19 vaccine. Known as KOSTAIVE, this vaccine targets the JN.1 lineage of Omicron subvariants specifically for adults aged 18 and older.

Distribution by Meiji Seika Pharma

In a pivotal move, CSL's exclusive partner in Japan, Meiji Seika Pharma, is set to begin distribution of KOSTAIVE. As Japan gears up for its October COVID-19 vaccination campaign, this rollout signifies the first instance of an sa-mRNA vaccine being commercially available for adults in the country.

Regulatory Recommendations for Updated Vaccines

A recent recommendation from a Japanese health ministry panel emphasized the need to update COVID-19 vaccines to combat the JN.1 lineage for the national immunization program of 2024/2025. This recommendation aligns with guidance from international health authorities, showcasing a synchronized effort to combat evolving strains of COVID-19.

Statements from Leading Executives

CSL’s Senior Vice President Emmanuelle Lecomte-Brisset expressed enthusiasm about receiving approval, stating, “We remain on track to distribute KOSTAIVE in time for the October COVID-19 vaccination campaign.” Meanwhile, Jonathan Edelman, M.D., also from CSL, highlighted the significance of this approval, reinforcing CSL’s commitment to innovative healthcare solutions.

Clinical Evidence Supporting KOSTAIVE

The regulatory approval hinges on robust clinical trial data showcasing the safety and effectiveness of this innovative vaccine. Notably, studies revealed that KOSTAIVE provides superior immunogenicity compared to traditional mRNA COVID-19 booster vaccines. Furthermore, the data indicates a durability of immunity lasting up to one year, bolstering confidence in the long-term efficacy of the vaccine.

Global Context and Health Impact

In an era where COVID-19 continues to pose global health challenges, Arcturus Therapeutics CEO Joseph Payne expressed optimism about the potential impact of their sa-mRNA technology. “Our technology will play a crucial role in vaccinating individuals in Japan, as we combat the ongoing threat to public health.” This sentiment resonates with CSL's mission to provide innovative treatment options to safeguard communities.

Understanding sa-mRNA Technology

Self-amplifying mRNA vaccines deliver a remarkable advance over traditional methods. They not only instruct the body to produce the necessary proteins to provoke an immune response but also enhance that response by creating more mRNA. This technology is particularly crucial in addressing infectious diseases, including COVID-19.

About CSL and Its Global Impact

CSL has been a beacon in the biotechnology industry since its inception in 1916. With a diverse range of lifesaving medicines, including those for hemophilia, vaccines preventing influenza, and therapies addressing iron deficiency, CSL continues to positively influence global health. The company operates three divisions—CSL Behring, CSL Seqirus, and CSL Vifor—and serves patients in over 100 countries with an impressive workforce of 32,000 dedicated individuals.

Learn More About Arcturus Therapeutics

Established in 2013, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) stands at the forefront of mRNA medicines and vaccine technologies. Their platforms utilize advanced delivery and manufacturing processes, positioning them as leaders in the field. Arcturus is involved in various collaborations for innovative mRNA products, enhancing their portfolio that includes vaccine programs for COVID-19 and influenza among other treatments.

About Meiji Seika Pharma Co., Ltd.

Meiji Seika Pharma has a long-standing history since the launch of penicillin in 1946. The company specializes in delivering high-quality pharmaceutical products, focusing on therapeutics for infectious diseases and central nervous system disorders. As a key player in infection control, Meiji Seika continues to enhance its capabilities in vaccine development and antimicrobial solutions.

Frequently Asked Questions

What is KOSTAIVE?

KOSTAIVE is an updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine developed by CSL and Arcturus Therapeutics, targeting the JN.1 Omicron lineage.

Who will distribute KOSTAIVE in Japan?

Meiji Seika Pharma will handle the distribution of KOSTAIVE in Japan, aligning with the country’s upcoming COVID-19 vaccination campaign.

What is unique about sa-mRNA vaccines?

Sa-mRNA vaccines enhance the immune response by directing the body to create more mRNA and protein, leading to a stronger and longer-lasting immunity.

When is the expected rollout of the vaccine?

The rollout is scheduled for October, coinciding with Japan’s COVID-19 vaccination campaign.

What does CSL aim to achieve with KOSTAIVE?

CSL aims to improve public health outcomes by providing innovative and effective vaccine options against COVID-19.

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